Field of the Invention
The present invention relates to a herbal composition for treating metastatic breast cancer.
Description of Prior Art
Breast cancer, a leading cause of morbidity and mortality among women, was estimated to account for 23% (1.38 million) of new cancer cases and 14% (458,400) of cancer deaths worldwide in 2008. In Taiwan, breast cancer was the most common cancer among women, with an incidence of 9,049 cases per 100,000 population, and the fourth leading cause of cancer-related deaths in 2008. Despite advances in the treatment of breast cancer, it is estimated that 30-50% of women initially diagnosed with earlier stages of breast cancer eventually develop metastatic disease. Unfortunately, breast cancer has a poor prognosis following metastasis, and women with metastatic breast cancer have a limited survival of 18-24 months, and a 5-year survival rate of approximately 20%. The progression to metastatic disease is further exacerbated by the increasing use of chemotherapy in early-stage breast cancer, which has led to a corresponding increase in the number of metastatic breast cancer cases refractory to conventional treatments.
The currently available conventional treatment options for metastatic breast cancer include cytotoxic chemotherapy, endocrine/hormonal therapy, targeted biological therapy, radiation therapy, bisphosphonates, or combinations of these, and surgery in some cases. However, there is no global consensus and guidelines for the treatment of metastatic breast cancer, and treatment is highly individualized and varies worldwide. Furthermore, due to the poor prognosis of metastatic breast cancer, the main goals of treatment are palliative rather than curative. Specifically, treatment is aimed at prolonging progression-free survival (PFS) and overall survival (OS), managing or reducing disease symptoms, and achieving the best quality of life (QOL). However, the significant side effects, potential for the development of treatment resistance, and limited survival benefit associated with conventional treatments has prompted the use of complementary and alternative medicine (CAM) in patients with advanced malignancies.
The use of CAM has been on the rise, especially among patients with life-threatening diseases, such as cancer. In fact, it has been estimated that 48-98% of breast cancer patients use CAM, and the most commonly used CAM is herbal medicine. There are numerous reasons cited by breast cancer patients for using CAM, including strengthening the immune system, increasing QOL, treating or preventing the recurrence of cancer, stabilizing current condition, alleviating cancer-related symptoms, assisting conventional treatments, relieving symptoms and stress associated with side effects of conventional treatments, providing a feeling of control over life, reducing stress and detoxification, and compensating for failed conventional medical treatments. Although CAM is widely used by breast cancer patients, their safety and efficacy have been studied in very few randomized and controlled clinical trials.
Tien-Hsien Liquid Practical (THL-P), a Chinese herbal mixture, has been used as a CAM for over ten years. Recently, THL-P has been shown to have strong immunomodulating and anticancer effects via a number of preclinical in vitro and in vivo experiments. Specifically, THL-P has been shown to modulate the antigen-stimulated proliferation response and cytokine production of T-lymphocytes, inhibit cell growth and induce apoptosis in various human cancer cell lines, and possess anti-tumour, anti-angiogenic, anti-metastatic effects. Based on these promising findings, the inventors performed a randomized, double-blind, placebo-controlled, parallel-group, phase IIa pilot trial to evaluate the safety and efficacy profiles of THL-P in patients with metastatic breast cancer refractory to conventional treatments.